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Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02743351
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Brief Summary:
This study is a Phase 1, Non-randomized, Open-label/Phase 2 Randomized, Blinded Study of ProTmune (ex vivo programmed mobilized peripheral blood cells) Versus Non-programmed mobilized peripheral blood cells for Allogeneic Hematopoietic Cell Transplantation (HCT) in Adult Subjects Aged 18 years and older with Hematologic Malignancies. A maximum of 80 total eligible subjects will be enrolled and treated in the trial at approximately 15-20 centers in the US.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia Acute Graft-versus-host Disease Biological: ProTmune Biological: Control Arm Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1, Non-randomized, Open-Label/ Phase 2 Randomized, Blinded Study of ProTmune™ (ex Vivo Programmed Mobilized Peripheral Blood Cells)Versus Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult Subjects With Hematologic Malignancies Patients With Hematologic Malignancies
Actual Study Start Date : June 2016
Actual Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: ProTmune Biological: ProTmune
Ex-vivo, programmed mobilized peripheral blood (mPB) cells

Active Comparator: Control Arm Biological: Control Arm
Untreated mobilized peripheral blood (mPB) cells




Primary Outcome Measures :
  1. Number of patients that experience Grades II-IV acute Graft vs Host Disease (aGvHD) [ Time Frame: by Day 100 ]
    aGvHD assessments of skin, liver and gastrointestinal involvement will be required to calculate the incidence of Grades II through IV (CIBMTR) aGvHD


Secondary Outcome Measures :
  1. Subjects alive without relapse and moderate to severe chronic Graft vs Host Disease (cGvHD) [ Time Frame: By Day 365 ]
    Proportion of Subjects alive without relapse and without moderate or severe cGvHD at Visit Day +365



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male and female patients aged 18 years and older, inclusive;
  2. Patients must have a hematologic malignancy for which allogeneic hematopoietic peripheral blood cell transplantation is deemed clinically appropriate.

    Eligible diseases and stages include the following:

    1. Acute myeloid leukemia
    2. Acute lymphoblastic leukemia, including T lymphoblastic lymphoma with a history of marrow involvement
    3. Myelodysplatic Syndrome
    4. Chronic Myelogenous leukemia
  3. Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;
  4. mBP donor collection that meets protocol specifications;
  5. Adequate performance status, defined as Karnofsky score greater than 70%;
  6. For female patients of childbearing potential, all of the following criteria must be met:

    • They are not pregnant (i.e., female patients must have a negative serum pregnancy test at screening);
    • They are not breastfeeding;
    • They do not plan to become pregnant during the study; and
    • They are using an effective method of contraception from screening to the end of the study, unless their sexual partner is surgically sterile
  7. For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and
  8. Willingness and ability to sign an IRB/IEC approved ICF before performance of any study specific procedures or tests and to comply with protocol visits, and study procedures.

Key Exclusion Criteria:

  1. Phase 1 only: known bone marrow fibrosis; Phase 2 only: Bone marrow fibrosis grade 3 (severe) or greater;
  2. Positive serology for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) at any time prior to enrollment;
  3. Currently uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms despite therapy);
  4. Prior autologous or allogeneic HCT;
  5. Active malignancy, other than the one for which the allogeneic mPB transplant is being performed, within 12 months of enrollment, excluding superficial basal cell and carcinoma in situ cervical cancer;
  6. Pulmonary disease, renal dysfunction, hepatic disease, cardiac disease, neurologic disease;
  7. Participation in another clinical trial involving an investigational product within 30 days prior to screening; or
  8. Any condition or therapy, which, in the opinion of the Investigator, might pose a risk to the patient or make participation in the study not in the best interest of the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743351


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States
United States, California
City of Hope
Duarte, California, United States, 91010
University of California, San Diego (UCSD) Moores Cancer Center
San Diego, California, United States
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Indiana
Indiana Blood and Marrow Transplant
Indianapolis, Indiana, United States, 46237
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Weill Cornell Medicine
New York, New York, United States
United States, Ohio
Jewish Hospital
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Transplant Institute
San Antonio, Texas, United States
United States, Utah
Huntsman Cancer Institute (University of Utah)
Salt Lake City, Utah, United States, 84103
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: Sarah Cooley, MD Fate Therapeutics
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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT02743351    
Other Study ID Numbers: PT-001
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fate Therapeutics:
Cell Transplants
Hematopoietic Cell Transplant
HSCT
Hematologic Malignancies
Hematologic Malignancy
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
ALL
AML
Myelodysplastic Syndrome
MDS
Allogeneic
CML
Stem Cell Transplant
Transplant
aGvHD
Acute graft-versus-host Disease
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Neoplasms
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hematologic Neoplasms
Myelodysplastic Syndromes
Graft vs Host Disease
Neoplasms by Histologic Type
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Neoplasms by Site